We’ve waited six years for the FDA’s latest guidance docs
The FDA admitted “regulatory ambiguity” is hampering technology innovation in healthcare. The agency released three guidance docs last week in an effort to clarify. Developers have waited six years for one: FDA will generally not regulate “clinical decision support tools that allow the provider to independently review the basis for the recommendations.” But some feel the agency didn’t go far enough. There was no mention of how they plan to regulate AI nor hint of adopting a risk-based approach, for example.